FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3212698
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10052
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 29, 2013
- Report Date
- May 29, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE DEFIBRILLATION LEAD, THE LEAD WAS REPOSITIONED A COUPLE OF TIMES AND PERFORATED THE HEART WALL RESULTING IN A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TAT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS LATER OBSERVED TO BE IN STABLE CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313274 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L| R | E160| 0292 |